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Activity Number: 331 - Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology, and Cross-Disciplinary Scientific Engagement
Type: Topic Contributed
Date/Time: Tuesday, August 1, 2017 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #323474 View Presentation
Title: Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology and Cross-Disciplinary Scientific Engagement
Author(s): Greg Ball* and Frank Rockhold* and Janet Wittes* and Ana Szarfman* and William W Wang*
Companies: Merck and Retired and Statistics Collaborative, Inc. (SCI) and CDER, FDA and Merck & Co Inc
Keywords: aggregate safety monitoring ; cross-disciplinary scientific engagement ; quantitative scientists
Abstract:

In an effort to protect patient safety and enhance public health, there is growing interest in developing a systematic approach for safety evaluation of pharmaceutical products, both for pre-marketing safety monitoring as well as for post-marketing safety surveillance. Recent regulatory documents, such as ICH guidelines (DSUR, PBRER) and FDA IND safety reporting guidances (2012, 2015), have highlighted the importance of aggregate safety monitoring. Biostatisticians and other quantitative scientists should closely engage with clinical and regulatory scientists in order to play a vital role in these efforts. This session brings together panelists from academia, industry, and a regulatory agency to share their statistical, cross-disciplinary and regulatory perspectives on safety monitoring during pharmaceutical product development. Our fifth speaker, the chair of the ASA Biopharm Safety Monitoring working group, will share the group's efforts to empower the biostatistics community to play a more proactive role and better enable quantification in safety monitoring.

Organizer: Greg Ball, Chair: Judy Li Panelists: Frank Rockhold, Janet Wittes, Ram Tiwari,Ana Szarfman, William Wang


Authors who are presenting talks have a * after their name.

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